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A randomized, double blind, high dose versus low dose parallel control, multicenter clinical trial for assessment of effect and safety for Qidan Bimin Wan in the treatment of seasonal allergic rhinitis (Lung and Spleen Qi deficiency type (TCM zheng)), a phase III study

A randomized, double blind, high dose versus low dose parallel control, multicenter clinical trial for assessment of effect and safety for Qidan Bimin Wan in the treatment of seasonal allergic rhinitis (Lung and Spleen Qi deficiency type (TCM zheng)), a phase III study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003137
Enrollment
Unknown
Registered
2013-03-29
Start date
2013-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

seasonal allergic rhinitis (Lung and Spleen Qi deficiency type (TCM zheng))

Interventions

High dose:High dose of Qidan Bimin Wan
Low dose:Low dose of Qidan Bimin Wan

Sponsors

Orental Hospital, Beijing University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The patient to be confirmed with seasonal allergic rhinitis, the course more than 2 years, onseted in special season, less than two months during each onset and less than one week in this onset; 2. According to the TCM zheng "Lung and Spleen deficiency"; 3. Aged 18 to 60 years; 4. Positive response for skin point puncture test (seasonal allergens) and/or serum special IgE test with positive response; 5. At least two nose main symptoms with moderate and higher grade (higher than 2 scorse); 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient with severe liver and kideny disease or liver and kideny function obviousely abnormal (ALT=2ULN, Cr>ULN); 2. Patient with upper resperitory tract infection, chronic obstructive pulmonary disease, pulmonary fibrosis, asthma (expect mild intermittent asthma (according to the NAEPP guideline); 3. chronic or intermittent use section, oral, intramuscular injection, intravenous injection, and/or super powerful or topical corticosteroids; 4. Use long-term antihistamines; 5. Taking illegal drugs or for certain categories of drug withdrawal time is insufficient: Intranasal or systematically use of corticosteroids less than one month; Intranasal used coloring nucleotide less than two weeks; Intranasal or systematically used of decongestant agent less than 3 days; Intranasal or systematically used antihistamines less than 3 days; Used loratadine less than 10 days; 6. Patient with non allergic rhinitis, sinusitis, nasal polyps, correlation severe nasal septum deviation, eye infections; 7. Patient has diabetes history or fast blood surgar level higher than the higher threshold of normal volue; 8. Patient long term use along with medicines, such as tricyclic antidepressants; 9. Patient with allergy history to test drugs ingredients; 10. Patient attended other clinical study within 3 months before include this trial; 11. Patient with severe mental and neurological diseases; 12. Patient with uncontrolled hypertention; 13. Pregnancy, lactation period woman, or childbearing age woman unable to use effective measures for contraception; 14. Person has illicit drugs history; Or the person who has a history of alcoholism and during the test cannot terminate alcoholics; 15. Any person who to be considered not suite to attending this research.

Design outcomes

Primary

MeasureTime frame
All nose symptoms score;

Secondary

MeasureTime frame
All nose symptoms and local physical signs;Eyes along with symptoms scores;Local physical signs (nasal cavity examination) scores;TCM signs scores;Single symptom clearance rate;Quality of life;Remission time of all nose symptom;

Countries

China

Contacts

Public ContactOu Yi
ouyitiantang@yahoo.com.cn+86 13717870071

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026